Low Back PainPhase 4NCT00404079

The Glucosamine-study: The Effect of Glucosamine in Treatment of Chronic Low Back Pain

A Phase 4 study testing Glucosamine sulphate in people with Low Back Pain, run by Ullevaal University Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 years and olderHealthy volunteers can take part
Conditions the study is for: Low Back Pain
What is being tested?: Glucosamine sulphate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 250 participants
Where: 1 siteNorway
Study dates: Dec 2006to Nov 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Low back pain for more than 6 months
Patient older than 25 years old
MRI findings comparable with lumbar degenerative/osteoarthritic changes.

Who cannot join

Spinal stenosis with neurological deficits
Spinal prolapse with neurological deficits
Rheumatoid arthritis, psoriatic arthritis,
Old lumbar fractures
Chronic pain syndromes (e.g. fibromyalgia)
Psychosocial status not suitable for participation

Show all 9Show fewer

Pregnancy
Breastfeeding
Allergic to shellfish

Trial locations and contacts

1 site in 1 country.

Norway1 site

Ulleval Universtiy Hospital
Oslo, Oslo, 0450

Other trials in Norway

About this study

Official title: Phase 4 Study of Glucosamine Sulphate in the Treatment for Chronic Low Back Pain Patients With Degenerative Lumbar MRI Findings

Low back pain (LBP) is the most frequent cause of sick leave and disability pension, and degenerative and osteoarthritic (OA) changes is a significant cause of pain and disability. Some indications exist for symptomatic and possible cartilage-structurmodifying effect on knee- and hip-osteoarthritis with glucosamine sulphate (GS). The OA process in the lumbar spine is most likely to OA processes in knees and hips, hence GS could have comparable symptomatic and structural effect on lumbar OA.

Study hypothesis: No difference in treatment effect exists between oral intake of GS- or placebo-capsules for patients' with chronic low back pain measured with Roland Morris Disability Questionnaire.

Conditions: Low Back Pain
Being tested: Glucosamine sulphate, Placebo
Keywords: Chronic low back pain
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Glucosamine sulphateDrug
Also called Glucosamine sulfata Pharma Nord
Oral intake of 1500 mg glucosamine sulfate(from Pharma Nord) daily for 6 months
PlaceboDrug
Oral intake of 3 placebo capsules (similiar looking to the glucosamine sulfate capsules)daily for 6 months

Study groups in NCT00404079
Study group	Role	What they receive
Glucosamine Sulphate	Experimental	Not described Receives: Drug: Glucosamine sulphate
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Roland Morris Disability Questionnaire
The primary outcome was scores on the Norwegian version of Roland Morris Disability Questionnaire (RMDQ). RMDQ is a widely used back-specific, self-administered measure of pain-related disability. Greater levels of disability give higher numbers on a 24-point scale. RMDQ has content and construct validity and internal consistency. It is also reproducible and sensitive to change over time for LBP patients. A 3-point reduction in the total RMDQ was a priori classified as a response to treatment.
Measured: 1 year

Secondary outcomes (2)

Visual Analogue Scale
Measured: 1 year
EuroQol-5D
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2006Nov 2010

First posted27 Nov 2006 (estimated)
Study startDec 2006
Primary completionAug 2009
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00404079
Sponsor's protocol ID: 28130805
Status last verified: Feb 2011
First submitted: 23 Nov 2006
Last updated: 29 Apr 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Wilkens P, Scheel IB, Grundnes O, Hellum C, Storheim K. Effect of glucosamine on pain-related disability in patients with chronic low back pain and degenerative lumbar osteoarthritis: a randomized controlled trial. JAMA. 2010 Jul 7;304(1):45-52. doi: 10.1001/jama.2010.893.
PubMed 20606148
Wilkens P, Storheim K, Scheel I, Berg L, Espeland A. No effect of 6-month intake of glucosamine sulfate on Modic changes or high intensity zones in the lumbar spine: sub-group analysis of a randomized controlled trial. J Negat Results Biomed. 2012 Aug 17;11:13. doi: 10.1186/1477-5751-11-13.
PubMed 22900984
Wilkens P, Scheel IB, Grundnes O, Hellum C, Storheim K. Prognostic factors of prolonged disability in patients with chronic low back pain and lumbar degeneration in primary care: a cohort study. Spine (Phila Pa 1976). 2013 Jan 1;38(1):65-74. doi: 10.1097/BRS.0b013e318263bb7b.
PubMed 22718223

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 4 Study of Glucosamine Sulphate in the Treatment for Chronic Low Back Pain Patients With Degenerative Lumbar MRI Findings
ClinicalTrials.gov ID: NCT00404079
Acronym / sponsor ID: 28130805
Conditions: Low Back Pain
Keywords: Chronic low back pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 250 participants (actual)
Lead sponsor: Ullevaal University HospitalUniversity, hospital or other
Collaborators: Stiftelsen Helse og Rehabilitering
Study start: Dec 2006
Primary completion: Aug 2009 (actual)
Study completion: Nov 2010 (actual)
First posted: 27 Nov 2006 (estimated)
Results: Posted 29 Apr 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Glucosamine Sulphate	Experimental	Drug: Glucosamine sulphate
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 25 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Low back pain for more than 6 months
Patient older than 25 years old
MRI findings comparable with lumbar degenerative/osteoarthritic changes.

Key exclusion criteria (9 listed)

Spinal stenosis with neurological deficits
Spinal prolapse with neurological deficits
Rheumatoid arthritis, psoriatic arthritis,
Old lumbar fractures
Chronic pain syndromes (e.g. fibromyalgia)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Glucosamine sulphateAlso: Glucosamine sulfata Pharma NordOral intake of 1500 mg glucosamine sulfate(from Pharma Nord) daily for 6 months	Drug	Glucosamine Sulphate
PlaceboOral intake of 3 placebo capsules (similiar looking to the glucosamine sulfate capsules)daily for 6 months	Drug	Placebo

Primary outcome

Roland Morris Disability Questionnaire
Time frame: 1 year
The primary outcome was scores on the Norwegian version of Roland Morris Disability Questionnaire (RMDQ). RMDQ is a widely used back-specific, self-administered measure of pain-related disability. Greater levels of disability give higher numbers on a 24-point scale. RMDQ has content and construct validity and internal consistency. It is also reproducible and sensitive to change over time for LBP patients. A 3-point reduction in the total RMDQ was a priori classified as a response to treatment.

2 secondary outcomes

Visual Analogue Scale
Time frame: 1 year
EuroQol-5D
Time frame: 1 year

Results and safety

Results posted to the registry on 29 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Glucosamine Sulphate	125	103
Placebo	125	105

Primary outcome: Roland Morris Disability Questionnaire

Time frame: 1 year. Mean (Standard Deviation). Unit: units on a scale (0-24)

Measure	Placebo n = 125	Glucosamine Sulphate n = 125
Value	9 (4)	9 (4)

Placebo: Odds Ratio (OR): 4.5, p = 0.05, Mixed Models Analysis
Placebo: p = 0.05, Mixed Models Analysis

Population analysed: The number of participants for analysis followed the intention to treat principle. Imputation was performed with mulitple imputation.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Reports of adverse events were collected during the intervention period of 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Glucosamine Sulphate	0 of 125 (0%)	0 of 125 (0%)	Not reported
Placebo	0 of 125 (0%)	0 of 125 (0%)	Not reported

Limitations and caveats (from the sponsor): Free participation and the focus on glucosamine may attract a certain type of patients with specific personality traits. Adjunctive management was permitted, which may influence outcome. Compliance was assessed by capsule counts.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20606148Wilkens P, Scheel IB, Grundnes O, Hellum C, Storheim K. Effect of glucosamine on pain-related disability in patients with chronic low back pain and degenerative lumbar osteoarthritis: a randomized controlled trial. JAMA. 2010 Jul 7;304(1):45-52. doi: 10.1001/jama.2010.893.
Derived from this study: PubMed 22900984Wilkens P, Storheim K, Scheel I, Berg L, Espeland A. No effect of 6-month intake of glucosamine sulfate on Modic changes or high intensity zones in the lumbar spine: sub-group analysis of a randomized controlled trial. J Negat Results Biomed. 2012 Aug 17;11:13. doi: 10.1186/1477-5751-11-13.
Derived from this study: PubMed 22718223Wilkens P, Scheel IB, Grundnes O, Hellum C, Storheim K. Prognostic factors of prolonged disability in patients with chronic low back pain and lumbar degeneration in primary care: a cohort study. Spine (Phila Pa 1976). 2013 Jan 1;38(1):65-74. doi: 10.1097/BRS.0b013e318263bb7b.

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Oliver Grundnes, MD principal investigator

Ullevaal University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Glucosamine sulphate in people with Low Back Pain, run by Ullevaal University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Roland Morris Disability Questionnaire (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00404079, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2011.